Cantrol HDL Cholesterol Precipi. Reag. and Tubes
FDA 510(k) K882488 · Canyon Diagnostics, Inc.
510(k) numberK882488
Submission
- Device name
- Cantrol HDL Cholesterol Precipi. Reag. and Tubes
- Applicant
- Canyon Diagnostics, Inc.
Anaheim, CA, US - Received
- June 16, 1988
- Decision date
- August 15, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LBR – Ldl & Vldl Precipitation, Hdl
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LBR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143691 | LDLC3 LDL-Cholesterol Gen.3LBR · Traditional | Roche Diagnostics Operations (Rdo) | 01/28/2015SE |
| K072523 | Diazyme Ldl-Cholesterol Reagent, Calibrator and ControlsLBR · Traditional | General Atomics | 01/22/2008SE |
| K050823 | Direct HDL Cholesterol and Direct Hdl/Ldl CalibratorLBR · Traditional | Teco Diagnostics | 07/26/2005SE |
| K023784 | Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerLBR · Special | Hemagen Diagnostics, Inc. | 12/24/2002SE |
| K012593 | Vitros Chemistry Products Magnetic Hdl-Cholesterol Reagent, Vitros Chemistry Products…LBR · Special | Ortho-Clinical Diagnostics, Inc. | 08/30/2001SE |
| K992029 | Atac Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | Elan Diagnostics | 08/12/1999SE |
| K992002 | Autohdl Cholesterol Reagent SetLBR · Traditional | Pointe Scientific, Inc., | 08/05/1999SE |
| K991789 | Atac-Pak Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | Elan Holdings, Inc. | 07/09/1999SE |
| K990247 | MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470LBR · Traditional | Polymer Technology Systems, Inc. | 05/28/1999SE |
| K984303 | Vitros Chemistry Products Magnetic Hdl-Cholesterol ReagentLBR · Traditional | Ortho-Clinical Diagnostics, Inc. | 01/28/1999SE |
More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970248 | Cantrol Serum Iron and Total Iron Binding Capacity Test SystemJQE · Traditional | 02/11/1997SE |
| K964640 | Cantrol Iron/Tibc Controls, Level 1 and Level 2 Product Numbers: Level 1: IIBC-91 and…JJY · Traditional | 12/13/1996SE |
| K871537 | Cantrol HDL Cholestrol Controls Levels I and IIJJY · Traditional | 05/06/1987SE |
| K855006 | Cantrol Ck/Mb ControlJJT · Traditional | 01/17/1986SE |
| K854931 | Cantrol Electrophoresis ControlJJY · Traditional | 01/17/1986SE |
| K854190 | Cantrol Spinal Fluid ControlDFI · Traditional | 11/25/1985SE |
| K853603 | Cantrol Urine Dipstick Control Two LevelsJJW · Traditional | 10/08/1985SE |
| K852138 | Wescor Stain Pack for Model 7100 Aerospray Slide SIAF · Traditional | 06/13/1985SE |
Questions and answers
When was Cantrol HDL Cholesterol Precipi. Reag. and Tubes cleared by the FDA?
Cantrol HDL Cholesterol Precipi. Reag. and Tubes (K882488) received a 510(k) decision of Substantially Equivalent on August 15, 1988, 60 days after the submission was received.
What is the product code of K882488?
The FDA product code is LBR – Ldl & Vldl Precipitation, Hdl, a Class I (low risk) device regulated under 21 CFR 862.1475.